Esposolin - instructions for use, dose, side effects, contraindications

Excipients: benzalkonium chloride 0.2 mg, citric acid monohydrate 0.5 mg; glycerol 85% - 28.2 mg; sodium citrate dihydrate 2.6 mg; purified water - 971.5 mg.

Description:

Transparent colorless liquid with a barely perceptible odor.

Pharmacotherapeutic group:The anticongestive agent is alpha-adrenomimetic.

ATX: & nbsp

R.01.A.A.07 Xylometazoline

Pharmacodynamics:

Xylometazoline is a derivative of imidazole with alpha-adrenomimetic action and vasoconstrictor properties. Xylometazoline causes narrowing of the blood vessels of the nasal mucosa, eliminating the edema and hyperemia of the nasal mucosa. Relieves nasal breathing in rhinitis. The action occurs in about 5-10 minutes and lasts for 6-8 hours, while the swelling of the nasal mucosa decreases and nasal breathing is facilitated, and the discharge of excreta is improved.

Pharmacokinetics:With topical application is practically not absorbed, the concentrations in the blood plasma are so small that they can not be determined by modern analytical methods.

Indications:

Apply to reduce the swelling of the nasopharyngeal mucosa with acute allergic rhinitis, acute respiratory disease with phenomena of rhinitis, sinusitis, pollinosis, otitis media.

Contraindications:

increased sensitivity to xylometazoline hydrochloride or other components of the drug; atrophic (dry) rhinitis; surgical interventions on the meninges (the state of transphoidal ectomy of the pituitary gland or other surgical interventions on the medulla); children up to 6 years of age.

Carefully:

This drug can be used only after careful weighing of risk factors and benefits when: simultaneous administration of monoamine oxidase inhibitors and other drugs that increase blood pressure;

increased intraocular pressure, especially in closed-angle glaucoma;

Cardiovascular diseases (coronary heart disease (angina pectoris),

increased blood pressure, tachycardia);

pheochromocytoma;

hyperthyroidism;

diabetes mellitus;

porphyria;

hyperplasia of the prostate; pregnancy and during breastfeeding.

Pregnancy and lactation:

A limited amount of data on the use of the drug in pregnancy does not allow to draw a conclusion about the effect of xylometazoline on pregnancy or on the condition of the fetus / newborn. To date, there are no other epidemiological data.

In animal experiments, when doses exceeding therapeutic are used, the presence of reproductive toxicity is indicated. The use of the drug during pregnancy is only possible with careful weighing of all risk factors / benefits.Since an overdose can cause the drug to enter the fetus's blood, do not exceed the recommended dosing regimen during pregnancy. It is not known whether xylometazoline in mother's milk. Therefore, taking the drug during breastfeeding is only possible if the risk / benefit factors are carefully observed. Since an overdose can lead to a decrease in the production of breast milk, during the use of the drug, do not exceed the recommended dosage.

Dosing and Administration:

Intranasally.

The drug should be used:

Adults and children over 6 years of age: 2-3 times a day for 1 dose (1 injection) in each nasal passage.

Before the first use, it is necessary to lift the bottle up and press the nasal spray several times until a uniform cloud appears.

The drug should not be used more than 3 times a day.

Side effects:

By frequency of development, side effects are in the following groups:

Very often: (> / = 1/10)

Often: (>/=1/100-<1/10)

Not often: (> / = 1 / 1.000 - <1/100)

Rarely: (> / = 1 / 10.000 - <1 / 1.000)

Very rarely: (<1 / 10,000)

It is not known: (there is no information on the occurrence of side effects on the basis of existing data)

Stonians of the nervous system:

Very rarely: anxiety, insomnia, fatigue (drowsiness, sedation), headache, paresthesia, hallucinations (mainly in children).

From the cardiovascular system:

Rarely: palpitations, tachycardia, increased blood pressure.

Very rarely: arrhythmia.

From the respiratory system, organs of the thorax and mediastinum:

Often: burning and dryness of the nasal mucosa, sneezing, hypersecretion.

Not often: after applying the drug, there may be increased edema of the nasal mucosa (reactive hyperemia), blood from the nose.

Very rarely: apnea in infants and newborns.

From the side of the musculoskeletal and connective tissue:

Very rarely: convulsions (especially in children).

From the immune system:

Not often: reactions of increased sensitivity (angio edema, skin rash, urticaria). From the sense organs:

Rarely: impaired vision.

Overdose:

Symptoms of central nervous system stimulation are feelings of fear, excitement, hallucinations and convulsions.

Symptoms of suppression of the central nervous system are lowering body temperature, lethargy, drowsiness and coma.

Possible development of the following symptoms: miosis, mydriasis, sweating, fever, pallor, cyanosis, nausea, tachycardia, bradycardia, cardiac arrhythmias, cardiac arrest, increased blood pressure, shock-like hypotension, pulmonary edema, respiratory failure and apnea.

In young children, overdose often dominates the central effects with convulsions, coma and bradycardia, apnea, as well as an increase in blood pressure, which follows the hypotension.

Treatment:

In severe overdose, the inpatient intensive care is indicated. Such measures as the reception of activated carbon, sodium sulfate or gastric lavage (when taking large amounts) should be carried out without delay, since xylometazoline absorbed quickly. With a decrease in blood pressure, selective alpha-blockers should not be used. Vasopressor agents

are contraindicated.

If necessary, use antipyretic, anticonvulsant and perform artificial ventilation with oxygen.

lower temperature, conduct anticonvulsant therapy and artificial ventilation with oxygen.

Interaction:

Simultaneous reception of xylometazoline and tricyclic antidepressants,

monoamine oxidase inhibitors such as tranylcypromine, drugs that increase blood pressure, can lead to an increase in blood pressure, so it should be possible to avoid simultaneous reception of these medications.

Special instructions:

The drug should not be used without interruption for more than 5-7 days.

Do not exceed the recommended dosage.

With prolonged use and overdose of rhinological drugs that help reduce swelling, their effect may be weakened. As a result of abuse of rhinological means, reactive hyperemia of the nasal mucosa (medicamentous rhinitis) and atrophy of the nasal mucosa can develop.

Since the drug contains benzalkonium chloride, as a preservative, especially with prolonged use, can swell edema of the nasal mucosa. If there is a suspicion of such a reaction (nasal congestion), it is necessary, if possible, to use a drug that does not contain preservatives.If such medicines are not available, you must use another dosage form.

Effect on the ability to drive transp. cf. and fur:

In therapeutic doses does not affect the ability to drive a car and to control machinery.

With the development of adverse reactions from the cardiovascular and nervous system, caution should be exercised when performing actions that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Nasal Spray 0,1%.

10 ml in a bottle of amber glass (hydrolytic, class III EP) with a spraying device and a nasal adapter with a protective cap. Each vial with instructions for use is placed in a cardboard box.

Packaging:nasal spray, 0.1% (vial) 10 ml x 1 (carton pack) (complete with nebulizer and nasal adapter with protective cap)

Storage conditions:At a temperature of no higher than 25 ° C.

After opening the vial, use the drug for 6 months. Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002224

Date of registration:10.09.2013

The owner of the registration certificate:Esparma GmbHEsparma GmbH Germany

Manufacturer: & nbsp

PHARMA WERNIGERODE, GmbH Germany

Representation: & nbspESPARMA GmbH ESPARMA GmbH Germany

Information update date: & nbsp10.09.2013

Illustrated instructions

Instructions

Espaloline® (Espazoline®)